US2016312301A1PendingUtilityA1

Microrna biomarkers for ovarian cancer

Assignee: THE FEINSTEIN INST MEDICAL RESPriority: Dec 20, 2013Filed: Dec 22, 2014Published: Oct 27, 2016
Est. expiryDec 20, 2033(~7.4 yrs left)· nominal 20-yr term from priority
C12Q 1/6886C12Q 2600/178C12Q 2600/118C12Q 2600/158A61K 33/24C12Q 2600/16A61K 33/243
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Claims

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of diagnosing ovarian cancer in a subject, comprising
 identifying the expression level of at least one diagnostic miRNA selected from the group consisting of miR-106a, miR-106b, miR-126, miR-1274a, miR-139-5p, miR-142-3p, miR-146a, miR-150, miR-16, miR-17, miR-191, miR-193a-5p, miR-30a-5p, miR-19b, miR-20a, miR-223, miR-24, miR-30b, miR-30c, miR-320, miR-328, miR-484, miR-486, miR-625-3p, miR-660, miR-720, miR-92a, miR-122-5p, miR-483-5p, and miR-127-4b in a biological sample from the subject, comparing the expression level of the at least one diagnostic miRNA to control expression levels, and diagnosing the subject as having or being at an increased risk of having ovarian cancer if the subject has a changed expression level of the one or more diagnostic miRNA.   
     
     
         2 . The method of  claim 1 , wherein the changed level is an increased level, and wherein the diagnostic miRNA is selected from the group consisting of miR-1274a, miR-625-3p, miR-720, miR-483-5p, and miR-1274b. 
     
     
         3 . The method of  claim 1 , wherein the changed level is a decreased level, and wherein the diagnostic miRNA is selected from the group consisting of miR-106a, miR-106b, miR-126-3p, miR-139-5p, miR-142-3p, miR-146a, miR-150, miR-16, miR-17, miR-191, miR-193a-5p, miR-19b, miR-20a, miR-223, miR-24, miR-30b, miR-30c, miR-320, miR-328, miR-484, miR-486, miR-660, miR-92a, and miR-122-5p. 
     
     
         4 . The method of  claim 3 , wherein the diagnostic miRNA is selected from the group consisting of miR-106a, miR-126-3p, miR-146a, miR-150, miR-16, miR-17, miR-19b, miR-20a, miR-223, miR-24, and miR-92a. 
     
     
         5 . The method of  claim 1 , wherein the subject is human. 
     
     
         6 . The method of  claim 1 , wherein the ovarian cancer is serous epithelial ovarian cancer. 
     
     
         7 . The method of  claim 1 , wherein the expression level of a plurality of diagnostic miRNAs are identified. 
     
     
         8 . The method of  claim 1 , wherein the biological sample is selected from the group consisting of blood, plasma, and serum. 
     
     
         9 . The method of  claim 1 , wherein the biological sample is plasma. 
     
     
         10 . The method of  claim 9 , wherein the plasma is ultracentrifuged before determining the level of diagnostic miRNA in the plasma. 
     
     
         11 . The method of  claim 1 , wherein the level of diagnostic miRNA is determined using a polymerase chain reaction amplification-based assay. 
     
     
         12 . The method of  claim 1 , further comprising the step of administering or prescribing a therapeutic agent targeted to ovarian cancer to a subject diagnosed as having ovarian cancer. 
     
     
         13 . A method of providing a prognosis for a subject having ovarian cancer, comprising
 identifying the expression level of at least one prognostic miRNA selected from the group consisting of miR-720, miR20a, miR-223, miR-126-3p, and miR-1290 in a biological sample from the subject, comparing the expression level of the at least one prognostic miRNA to control expression levels, and identifying the subject as having a poor prognosis if the subject has a changed expression level of the one or more prognostic miRNA.   
     
     
         14 . The method of  claim 13 , wherein the prognostic miRNA is miR-1290. 
     
     
         15 . The method of  claim 13 , wherein the subject is human. 
     
     
         16 . The method of  claim 13 , wherein the ovarian cancer is serous epithelial ovarian cancer. 
     
     
         17 . The method of  claim 13 , wherein the expression level of a plurality of prognostic miRNAs are identified. 
     
     
         18 . The method of  claim 13 , wherein the biological sample is selected from the group consisting of blood, plasma, and serum. 
     
     
         19 . The method of  claim 13 , wherein the biological sample is plasma. 
     
     
         20 . The method of  claim 13 , wherein the plasma is ultracentrifuged before determining the level of prognostic miRNA in the plasma. 
     
     
         21 . The method of  claim 13 , wherein the level of prognostic miRNA is determined using a polymerase chain reaction amplification-based assay. 
     
     
         22 . A kit for diagnosing ovarian cancer in a subject, comprising:
 one or more detector means specific for at least one diagnostic miRNA selected from the group consisting of miR-106a, miR-106b, miR-126-3p, miR-1274a, miR-139-5p, miR-142-3p, miR-146a, miR-150, miR-16, miR-17, miR-191, miR-193a-5p, miR-19b, miR-20a, miR-223, miR-24, miR-30b, miR-30c, miR-320, miR-328, miR-484, miR-486, miR-625-3p, miR-660, miR-720, miR-92a, miR-122-5p, miR-483-5p, and miR-127-4b   means for comparing the expression level of the at least one diagnostic miRNA to the level of a corresponding control, and   instructions for using the kit to diagnose a subject as having or being at an increased risk of having ovarian cancer when the expression level of the at least one diagnostic miRNA is changed compared to control expression levels.   
     
     
         21 . The kit of  claim 22 , wherein the changed level is an increased level, and wherein the diagnostic miRNA is selected from the group consisting of miR-1274a, miR-625-3p, miR-720, miR-483-5p, and miR-1274b. 
     
     
         22 . The kit of  claim 22 , wherein the changed level is a decrease level, and wherein the diagnostic miRNA is selected from the group consisting of miR-106a, miR-106b, miR-126-3p, miR-139-5p, miR-142-3p, miR-146a, miR-150, miR-16, miR-17, miR-191, miR-193a-5p, miR-19b, miR-20a, miR-223, miR-24, miR-30b, miR-30c, miR-320, miR-328, miR-484, miR-486, miR-660, miR-92a, and miR-122-5p. 
     
     
         23 . The kit of  claim 22 , wherein the kit includes a plurality of different detector means suitable for determining the expression level of a plurality of diagnostic miRNA.

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